On February 3, 2016 TapImmune, Inc. (TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer & metastatic disease, reported that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for its cancer vaccine TPIV 200 in the treatment of ovarian cancer (Press release, TapImmune, FEB 3, 2016, View Source;drug-administration-for-its-lead-vaccine-tpiv-200-in-the-treatment-of-ovarian-cancer-567496381.html [SID:1234508964]).

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The FDA has designated the investigation of multiple-epitope Folate Receptor Alpha Peptide Vaccine (TPIV 200) with GM-CSF adjuvant for maintenance therapy in subjects with platinum-sensitive advanced ovarian cancer who achieved stable disease or partial response following completion of standard of care chemotherapy, as a Fast Track Development Program.

Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug or biological product means that the FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product.

"We believe that the FDA’s decision to grant Fast Track designation to TPIV 200 for the treatment ovarian cancer significantly expedites our clinical development program. We look forward to starting Phase II trials in the near future to address this highly aggressive cancer", commented Dr. Glynn Wilson Chairman & CEO of TapImmune. "We believe that TPIV 200 has the potential to improve outcomes for ovarian cancer patients for whom current treatment modalities offer a relative short time to recurrence and a poor overall prognosis".

Approximately 21,290 women were diagnosed with ovarian cancer in 2015 and an estimated 14,180 will die from the disease according to the American Cancer Society. Because ovarian cancer tends to be detected at a later stage of the disease, the five-year survival rate for ovarian cancer is 45%. Current treatment options are surgery, radiation and chemotherapy. There is currently no FDA approved cancer vaccine available for ovarian cancer.

On February 3, 2016 Trillium Therapeutics Inc. (NASDAQ: TRIL; TSX: TR) a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it has initiated dosing in its Phase 1 clinical trial of TTI-621 (SIRPaFc), a novel checkpoint inhibitor of the innate immune system, in relapsed or refractory hematologic malignancies (Filing, 6-K, Trillium Therapeutics, FEB 3, 2016, View Source [SID:1234508956]).

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TTI-621 is an antibody-like fusion protein that blocks the inhibitory activity of CD47, a molecule that is overexpressed by a wide variety of tumors. CD47 binds to SIRPa on macrophages and delivers a "do not eat" signal that inhibits the ability of macrophages to engulf and destroy cancer cells. Preclinical studies have shown that TTI-621 has anti-tumor activity across a range of hematologic tumors.

"This is an exciting time for Trillium as we now emerge as a clinical stage oncology company evaluating a novel immune checkpoint inhibitor," commented Dr. Eric Sievers, Trillium’s Chief Medical Officer. "At a fundamental level, a cancer patient’s ineffective immune response allows the tumor to propagate unchecked. By blocking CD47, a key cell-surface protein that inhibits phagocytosis, we hope to summon a durable anti-tumor response in patients who are beset by cancer."

The two-part clinical trial is designed as a multi-center, open-label Phase 1a/1b trial, evaluating TTI-621 as a single-agent in patients with relapsed or refractory hematologic malignancies. During the dose escalation phase set to enroll up to 36 subjects, the safety, tolerability, pharmacokinetics and pharmacodynamics will be characterized to determine the optimal dose for subsequent enrollment in the expansion phase. In this second part of the trial, the safety and preliminary antitumor activity of TTI-621 at the optimal dose identified in the escalation phase will be explored in 12–15 subjects per hematologic malignancy type: indolent B-cell lymphoma, aggressive B-cell lymphoma, T-cell lymphoma, Hodgkin lymphoma, chronic lymphocytic leukemia, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome.

Trillium has proposed five trial sites including the Mayo Clinic, Columbia University Medical Center, City of Hope National Medical Center, The Colorado Blood Cancer Institute, and Tennessee Oncology.

On February 3, 2016 Mersana Therapeutics and Takeda Pharmaceutical Company Limited (TSE:4502) reported that they have entered a new strategic partnership granting Takeda rights to Mersana’s lead product candidate, XMT-1522, outside the United States and Canada (Press release, Takeda, FEB 3, 2016, View Source [SID:1234508955]). The deal also expands an existing collaboration between the companies to provide Takeda with additional access to Mersana’s Fleximer antibody-drug conjugate (ADC) platform and grants Mersana an option at the end of Phase 1 to co-develop and co-commercialize one of these programs in the United States. In addition, the companies will co-develop new payloads for use with ADCs.

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XMT-1522 is an investigational, Fleximer-based ADC therapy that targets HER2-expressing tumors, including breast, gastric and non-small cell lung cancers. Preclinical data suggest that XMT-1522 may have anti-tumor activity in patients with HER2 low-expressing cancers as well as in patients with HER2 high-expressing cancers that do not respond to currently available HER2-targeting therapies. Mersana anticipates filing an Investigational New Drug application (IND) for XMT-1522 with the U.S. Food and Drug Administration (FDA) in mid-2016.

"We believe XMT-1522 has the potential to make a dramatic difference for HER2 low-expressing patients who currently have limited treatment options, and are confident that our Fleximer-based technology can address significant patient needs not currently met by other ADC platform technologies," said Anna Protopapas, President and Chief Executive Officer, Mersana. "Takeda’s knowledge of oncology and commitment to ADCs as a key therapeutic approach make the company the best partner for us to progress our transformative platform and advance XMT-1522 into the clinic."

Takeda and Mersana will co-develop XMT-1522, and Mersana will lead execution of the Phase 1 trial. Mersana will retain full commercial rights in the United States and Canada while Takeda will have rights in rest of world. Beyond development and commercialization of XMT-1522, the expanded partnership also grants Takeda access to additional targets within Mersana’s Fleximer-based ADC platform, with Mersana retaining the right to select one program at the end of Phase 1 for co-development and co-commercialization in the United States. Takeda and Mersana will also work together, leveraging Takeda’s proprietary small molecule libraries, to identify and develop novel payloads that both parties will be able to use in new ADC therapies.

"This is our third collaboration with Mersana in less than two years. We see great potential for Mersana’s Fleximer technology, combined with our oncology expertise and resources, to extend the benefits of targeted therapy with ADCs to underserved cancer patient populations," said Andrew Plump M.D., Ph.D., Chief Medical and Scientific Officer, Takeda. "We, along with the global oncology community, have made great strides in our fight against cancer, and we know that achieving our aspiration to cure cancer relies on great partnerships and innovation. We look forward to progressing these collaborations and, together, advancing the science of cancer care."

Takeda signed agreements with Mersana through its wholly owned subsidiary, Millennium Pharmaceuticals, Inc., under which, Mersana will receive an upfront payment of $40 million and an additional payment of $20 million upon clearance of the IND for XMT-1522 by the FDA. Subject to the success of the XMT-1522 and ADC programs, Mersana is eligible to receive milestone payments of more than $750 million combined, as well as royalties. Takeda will also invest up to $20 million in equity in future rounds of Mersana financing.

About XMT-1522

XMT-1522 is an investigational, novel HER2-targeting therapy based on Mersana Therapeutics’ Fleximer immunoconjugate technology, and carries approximately 15 proprietary auristatin payload molecules. Preclinical data have demonstrated significant anti-cancer activity in breast, gastric and non-small cell lung cancers, including in HER2 low-expressing tumor models refractory to currently available therapies. Mersana and Takeda are co-developing XMT-1522. Mersana will be responsible for commercialization in the United States and Canada; Takeda will be responsible in rest of world.